US2026053802A1PendingUtilityA1

TREATMENT OF CANCER USING COMBINATION THERAPIES COMPRISING GDC-6036 and GDC-0077

64
Assignee: GENENTECH INCPriority: Apr 6, 2022Filed: Jul 14, 2025Published: Feb 26, 2026
Est. expiryApr 6, 2042(~15.7 yrs left)· nominal 20-yr term from priority
Inventors:MERCHANT MARK ANDREWSCHUTZMAN JENNIFER LEESHI ZHENSONG CHUNYANDHARIA NEEKESH VIJAYJOO STEPHANIE ROYER
A61K 31/553A61K 9/16A61K 9/0053A61P 35/00A61K 2300/00A61K 9/48A61K 9/20A61K 31/517
64
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Claims

Abstract

Provided herein are combination therapies comprising GDC-6036 and inavolisib and methods of using the same to treat cancer.

Claims

exact text as granted — not AI-modified
1 . A combination therapy comprising:
 (a) GDC-6036   
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof; and
 (b) inavolisib 
 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The combination therapy of  claim 1 , wherein GDC-6036 is an adipate salt thereof. 
     
     
         3 . The combination therapy of  claim 1 or 2 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered QD according to a dosing regimen comprising one or more cycles. 
     
     
         4 . The combination therapy of  claim 3 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered QD on days 1-21 of a dosing regimen comprising one or more 21-day cycles, wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered orally as a tablet or capsule. 
     
     
         5 . The combination therapy of  claim 3 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered QD according to a dosing regimen comprising one or more 28-day cycles, wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered orally as a tablet or capsule. 
     
     
         6 . The combination therapy of any one of  claims 1-5 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 50 mg-500 mg. 
     
     
         7 . The combination therapy of any one of  claims 1-6 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 700 mg, or 800 mg. 
     
     
         8 . The combination therapy of any one of  claims 1-6 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 100 mg, 200 mg, or 400 mg. 
     
     
         9 . The combination therapy of any one of  claims 1-6 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 200 mg. 
     
     
         10 . The combination therapy of any one of  claims 1-6 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 400 mg. 
     
     
         11 . The combination therapy of any one of  claims 1-10 , wherein inavolisib or a pharmaceutically acceptable salt thereof is administered QD according to a dosing regimen comprising one or more cycles. 
     
     
         12 . The combination therapy of  claim 11 , wherein inavolisib or a pharmaceutically acceptable salt thereof is administered QD on days 1-21 of a dosing regimen comprising one or more 21-day cycles. 
     
     
         13 . The combination therapy of any one of  claims 1-12 , wherein inavolisib or a pharmaceutically acceptable salt thereof is administered QD according to a dosing regimen comprising one or more 28-day cycles. 
     
     
         14 . The combination therapy of any one of  claims 1-13 , wherein the dosing regimen comprising a rest period wherein one or both of GDC-6036 and inavolisib is not administered. 
     
     
         15 . The combination therapy of any one of  claims 1-13 , wherein inavolisib is administered at an amount of about 3, 6, or 9 mg. 
     
     
         16 . The combination therapy of any one of  claims 1-15 , wherein inavolisib is administered at an amount of 6 mg. 
     
     
         17 . The combination therapy of any one of  claims 1-15 , wherein inavolisib is administered at an amount of 9 mg. 
     
     
         18 . The combination therapy of any one of  claims 1-17 , for use in treating lung cancer comprising a KRas G12C  mutation. 
     
     
         19 . The combination therapy of  claim 18 , wherein the lung cancer is non-small cell lung carcinoma (NSCLC). 
     
     
         20 . The combination therapy of any one of  claims 1-17 , for use in treating colorectal cancer (CRC) comprising a KRas G12C  mutation. 
     
     
         21 . The combination therapy of any one of  claims 1-20 , wherein the patient is evaluated for the presence of a KRasG12C mutation prior to administration. 
     
     
         22 . The combination therapy of any one of  claims 1-21 , wherein no evaluation for the presence of mutant PIK3CA is performed prior to administration. 
     
     
         23 . A method of treating lung cancer mediated by a KRas G12C  mutation in a patient having such a lung cancer, the method comprising administering an effective amount of a combination therapy comprising:
 (a) GDC-6036   
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof administered QD according to a dosing regimen comprising one or more cycles; and
 (b) inavolisib 
 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof administered QD according to the dosing regimen comprising one or more cycles. 
     
     
         24 . The method of  claim 23 , wherein the lung cancer is NSCLC. 
     
     
         25 . The method of  claim 23 or 24 , wherein the lung cancer is adenocarcinoma, squamous-cell lung carcinoma or large-cell lung carcinoma. 
     
     
         26 . A method of a solid tumor comprising a KRasG12C mutation in patient having such a cancer, said method comprising administering an effective amount of a combination therapy comprising:
 (a) GDC-6036   
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof administered QD according to a dosing regimen comprising one or more cycles; and
 (b) inavolisib 
 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof administered QD according to the dosing regimen comprising one or more cycles. 
     
     
         27 . The method of  claim 26 , wherein the solid tumor is colorectal cancer (CRC). 
     
     
         28 . The method of any one of  claims 23-27 , further comprising:
 (a) determining the absence or presence of a KRasG12C mutation in a sample taken from a patient with a suspected diagnosed cancer; and   (b) administering to the patient a combination therapy as described herein comprising an effective amount of GDC-6036 or a pharmaceutically acceptable salt thereof and inavolisib.   
     
     
         29 . A method of treating tissue agnostic cancer comprising a KRasG12C mutation in patient having such a cancer, said method comprising administering an effective amount of a combination therapy comprising:
 (i) determining the absence or presence of a KRasG12C mutation in a sample taken from a patient with a suspected diagnosed cancer; and   (ii) where the patient sample comprises a KRasG12C mutation, administering an effective amount of a combination therapy comprising:
 (a) GDC-6036 
   
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof administered QD according to a dosing regimen comprising one or more cycles; and
 (b) inavolisib 
 
       
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof administered QD according to a dosing regimen comprising one or more cycles. 
       
     
     
         30 . The method of any one of  claims 23-29 , wherein the dosing regimen comprises one or more 21-day cycles. 
     
     
         31 . The method of  claim 30 , wherein the dosing regimen comprises a rest period wherein one or both of GDC-6036 and inavolisib is not administered. 
     
     
         32 . The method of any one of  claims 23-29 , wherein the dosing regimen comprises one or more 28-day cycles. 
     
     
         33 . The combination therapy any one of  claims 23-32 , wherein GDC-6036 is an adipate salt thereof. 
     
     
         34 . The method of any one of  claims 23-33 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered orally as a tablet or capsule. 
     
     
         35 . The method of any one of  claims 23-34 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 50 mg-500 mg. 
     
     
         36 . The method of any one of  claims 23-35 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 700 mg, or 800 mg. 
     
     
         37 . The method of any one of  claims 23-36 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 100 mg, 200 mg, or 400 mg. 
     
     
         38 . The method of any one of  claims 23-37 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 200 mg. 
     
     
         39 . The method of any one of  claims 23-37 , wherein GDC-6036 or a pharmaceutically acceptable salt thereof is administered at an amount of about 400 mg. 
     
     
         40 . The method of any one of  claims 23-39 , wherein inavolisib is administered at an amount of about 3 mg, 6 mg, or 9 mg. 
     
     
         41 . The method of any one of  claims 23-40 , wherein inavolisib is administered at an amount of 6 mg. 
     
     
         42 . The method of any one of  claims 23-40 , wherein inavolisib is administered at an amount of 9 mg. 
     
     
         43 . The method of any one of  claims 23-42 , wherein the patient is not evaluated for the presence of mutant PIK3CA prior to administration. 
     
     
         44 . Use of a combination therapy comprising GDC-6036 or a pharmaceutically acceptable salt thereof and inavolisib or a pharmaceutically acceptable salt thereof for the treatment of lung cancer, CRC, or pancreatic cancer as described herein. 
     
     
         45 . The use of  claim 44 , wherein the cancer is lung cancer or CRC and further comprises a dosing regimen comprising: (i) administering GDC-6036 or a pharmaceutically acceptable salt thereof QD according to a dosing regimen comprising one or more cycles; and (ii) administering inavolisib QD according to the dosing regimen comprising one or more cycles. 
     
     
         46 . Use of a combination therapy comprising GDC-6036 or a pharmaceutically acceptable salt thereof and inavolisib or a pharmaceutically acceptable salt thereof for the manufacture of a medicament for the treatment of lung cancer, CRC, or pancreatic cancer. 
     
     
         47 . The use of  claim 46 , wherein the cancer is lung cancer or CRC and further comprises a dosing regimen comprising: (i) administering GDC-6036 or a pharmaceutically acceptable salt thereof QD according to a dosing regimen comprising one or more cycles; and (ii) administering inavolisib QD according to the dosing regimen comprising one or more cycles. 
     
     
         48 . The use of  claim 46 , wherein the cancer is CRC and further comprising a dosing regimen comprising: (i) administering GDC-6036 or a pharmaceutically acceptable salt thereof QD according to a dosing regimen comprising one or more 21-day cycles; and (ii) administering inavolisib according to a dosing regimen comprising one or more 21-day cycles. 
     
     
         49 . The use of any one of  claims 44-48 , wherein the dosing regimen comprises one or more 21-day cycles. 
     
     
         50 . The use of any one of  claims 44-48 , wherein the dosing regimen comprises one or more 28-day cycles.

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